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ELEMENT Blood Glucose Test Strip

INFS21AGR

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115901507
Basic UDI-DI: B-08809115901507
Reference: INFS21AGR
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Test Strip

INFS22A

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115901392
Basic UDI-DI: B-08809115901392
Reference: INFS22A
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

Gluco Check ExCEllent Blood Glucose Test Strip

INFS17B

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115901330
Basic UDI-DI: B-08809115901330
Reference: INFS17B
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

FINETEST Auto-coding premium Blood Glucose Test Strip

INFS16B

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115901293
Basic UDI-DI: B-08809115901293
Reference: INFS16B
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Croatia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Test Strip

INFCH001A

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900913
Basic UDI-DI: B-08809115900913
Reference: INFCH001A
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Test Strip

INFS001ACZ

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900883
Basic UDI-DI: B-08809115900883
Reference: INFS001ACZ
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Test Strip

INFM22AGR

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900678
Basic UDI-DI: B-08809115900678
Reference: INFM22AGR
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

Gluco Check ExCEllent Blood Glucose Control Solution (Normal)

INFM17BSV

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900654
Basic UDI-DI: B-08809115900654
Reference: INFM17BSV
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

FINETEST Auto-coding premium Blood Glucose Test Strip

INFM22AFR

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900647
Basic UDI-DI: B-08809115900647
Reference: INFM22AFR
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Test Strip

INFM22ANL

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900593
Basic UDI-DI: B-08809115900593
Reference: INFM22ANL
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

GCare Glucose Control Solution

GCare Glucose Control Solution

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663911
Basic UDI-DI: B-08806134663911
Reference: 0639C10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GBP-110

IVD Annex II List BIVDDOn the marketAnimal tissuesMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663713
Basic UDI-DI: B-08806134663713
Reference: GBP110S10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE PRIME Glucose Control Solution

GREENCARE PRIME Glucose Control Solution

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663515
Basic UDI-DI: B-08806134663515
Reference: 0635C10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE PRIME Blood Glucose Test Strip

GBP-100

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663416
Basic UDI-DI: B-08806134663416
Reference: GBP100S10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE LIPID TC Test Strip

GLC-100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663218
Basic UDI-DI: B-08806134663218
Reference: GLC100S10
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE LIPID Profile Test Strip

GLP-100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663119
Basic UDI-DI: B-08806134663119
Reference: GLP100S10
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

respons®A1c Hemoglobin A1c Test Kit

respons®A1c Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660750
Basic UDI-DI: B-08806134660750
Reference: 963207
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem A1c Advanced Hemoglobin A1c Test Kit

PocketChem A1c Advanced Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660743
Basic UDI-DI: B-08806134660743
Reference: 107033
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

QDx A1c Advance Test kit

QDx A1c Advance Test kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660729
Basic UDI-DI: B-08806134660729
Reference: RT100S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE A1c Hemoglobin A1c Test Kit

GREENCARE A1c Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660712
Basic UDI-DI: B-08806134660712
Reference: RT100S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details